Ocular Therapeutix(OCUL) - 2023 Q4 - Annual Results

Overview and Business Highlights Ocular Therapeutix has strategically advanced its retinal care pipeline, marked by key appointments, successful financing, and upcoming clinical data Recent Achievements & Strategic Direction Ocular Therapeutix has made significant strategic moves to position itself as a leader in retinal care, highlighted by key leadership appointments, including Pravin Dugel, MD as Executive Chairman. The company successfully initiated the Phase 3 SOL-1 trial for its lead candidate, AXPAXLI™ in wet AMD, and secured over $440 million in gross proceeds from recent financings to fund its clinical development programs - Appointed key strategic and clinical experts, including Pravin Dugel, MD, as Executive Chairman, to lead the company's focus on retinal care[3] - Initiated the Phase 3 SOL-1 trial for AXPAXLI™ in wet AMD, with the first subjects screened[1][3] - Raised over $440 million in gross proceeds from two recent financings to fund clinical development for AXPAXLI™ in wet AMD and diabetic retinopathy[2][3] Anticipated Milestones The company anticipates several key clinical data readouts in the second quarter of 2024, including topline results for PAXTRAVA™ in glaucoma and Phase 1 results for AXPAXLI™ in diabetic retinopathy. An Investor Day is also planned for Q2 2024 to outline the updated corporate strategy - Topline results from the Phase 2 trial of PAXTRAVA™ in glaucoma are expected at ASCRS on April 5-8[11] - Topline Phase 1 results from the HELIOS trial for AXPAXLI™ in diabetic retinopathy are expected in Q2 2024[1][11] - The company plans to host an Investor Day in Q2 2024 to provide updates on its corporate strategy[1][2][11] Financial Results The company reported increased revenue for FY2023, a widened net loss, and a strengthened cash position, detailed in its consolidated financial statements Fourth Quarter and Full Year 2023 Performance Ocular Therapeutix reported a 13.4% increase in total net revenue for the full year 2023, reaching $58.4 million, driven by DEXTENZA sales. The company's net loss widened to $(80.7) million for the year, influenced by increased R&D spending on clinical trials. The company ended 2023 with a strong cash position of $195.8 million, further bolstered by a $325 million financing in February 2024, providing a cash runway into at least 2028 - Cash and cash equivalents were $195.8 million at year-end 2023. A subsequent financing in February 2024 added $325 million in gross proceeds, extending the cash runway into at least 2028[1][4] | Metric | Q4 2023 (in millions) | Q4 2022 (in millions) | YoY Change | FY 2023 (in millions) | FY 2022 (in millions) | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total Net Revenue | $14.8M | $14.1M | +5.0% | $58.4M | $51.5M | +13.4% | | R&D Expenses | $16.2M | $13.5M | +20.0% | $61.1M | $53.5M | +14.2% | | Net Loss | $(29.2)M | $(15.5)M | +88.4% | $(80.7)M | $(71.0)M | +13.7% | | Net Loss per Share (basic) | $(0.35) | $(0.20) | - | $(1.01) | $(0.92) | - | Consolidated Financial Statements The consolidated financial statements detail the company's financial position and performance. The balance sheet shows a significant increase in total assets to $252.1 million in 2023 from $149.3 million in 2022, primarily due to a rise in cash. The statement of operations reflects revenue growth alongside increased operating expenses and a larger net loss for the full year 2023 compared to 2022 Consolidated Balance Sheets As of December 31, 2023, the company's balance sheet strengthened significantly, with cash and cash equivalents nearly doubling to $195.8 million. Total assets grew to $252.1 million, while total liabilities increased to $160.9 million, driven by changes in derivative liabilities and notes payable. Total stockholders' equity rose to $91.1 million from $35.4 million in the prior year | Balance Sheet Item (in thousands) | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $195,807 | $102,300 | | Total current assets | $232,235 | $129,627 | | Total assets | $252,060 | $149,289 | | Total liabilities | $160,929 | $113,910 | | Total stockholders' equity | $91,131 | $35,379 | Consolidated Statements of Operations For the full year 2023, total net revenue increased by 13.4% to $58.4 million. However, total costs and operating expenses also rose to $140.8 million, leading to a loss from operations of $(82.4) million. The net loss for 2023 was $(80.7) million, or $(1.01) per basic share, compared to a net loss of $(71.0) million, or $(0.92) per basic share, in 2022 | Statement of Operations (in thousands) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total revenue, net | $58,443 | $51,494 | | Total costs and operating expenses | $140,825 | $130,148 | | Loss from operations | $(82,382) | $(78,654) | | Net loss | $(80,736) | $(71,038) | | Net loss per share, basic | $(1.01) | $(0.92) | Company and Product Information Ocular Therapeutix is a biopharmaceutical company focused on eye disease therapies using its ELUTYX™ technology, including its commercial product DEXTENZA About Ocular Therapeutix, Inc. Ocular Therapeutix is a biopharmaceutical company focused on developing and commercializing therapies for eye diseases using its proprietary ELUTYX™ bioresorbable hydrogel technology. Its clinical pipeline is led by AXPAXLI™ for wet AMD and diabetic retinopathy, and PAXTRAVA™ for glaucoma. The company also has several other clinical and preclinical programs - The company's lead product candidate for retinal disease is AXPAXLI™, which is currently in Phase 3 trials for wet AMD and a Phase 1 trial for diabetic retinopathy[13] - The clinical portfolio also includes PAXTRAVA™ for primary open-angle glaucoma or ocular hypertension, currently in a Phase 2 trial[13] - The company's proprietary ELUTYX™ bioresorbable hydrogel technology is the foundation for its product candidates and its commercial product, DEXTENZA®[13][14] About DEXTENZA DEXTENZA is an FDA-approved corticosteroid intracanalicular insert for treating ocular inflammation and pain after ophthalmic surgery and ocular itching from allergic conjunctivitis. It is designed to deliver dexamethasone for up to 30 days and resorbs naturally without needing removal - DEXTENZA is FDA-approved for treating ocular inflammation and pain post-ophthalmic surgery and for ocular itching associated with allergic conjunctivitis[14][16] - It is a preservative-free insert that delivers dexamethasone to the ocular surface for up to 30 days and resorbs without requiring removal[16]